291. Striking a Balance: Drug Labeling and the FDA
- Author:
- John E. Calfee
- Publication Date:
- 02-2006
- Content Type:
- Policy Brief
- Institution:
- American Enterprise Institute for Public Policy Research
- Abstract:
- With the fourth Vioxx lawsuit currently under way, a fourth jury is in the thick of trying to determine whether Merck is indeed liable for any injuries that may or may not have arisen from the use of its blockbuster arthritis drug. The trials have highlighted bad tort bar science in all its dubious glory—from questionable pathology reports to seriously exaggerated claims about the dangers of Vioxx—but they also raise a deeper issue. Every drug presents patients and doctors with a trade-off between benefits and risks. But how can physicians and drug companies strike a balance in the age of a hyperactive litigation? Last week, the Food and Drug Administration (FDA) weighed in on that question when it published a long-awaited rule to simplify drug labels. Up to now, extensive, cringe-inducing lists of every imaginable side effect of a medicine were a drug company's best hope of immunizing itself from lawsuits down the road. The FDA wants to simplify those impenetrable reams of fine print by preempting state-court lawsuits claiming that an FDA-approved label failed to warn patients of a potential danger.
- Topic:
- Economics, Government, Health, and Human Welfare